Gum Therapy (Calendula Officinalis, Eugenia Caryophyllata, Plantago Major, Phytolacca Decandra, Arnica Montana, Phosphorus, Peptostreptococcus, Carbo Vegetabilis, Hepar Sulphuris Calcareum, L -

GUM THERAPY (CALENDULA OFFICINALIS, EUGENIA CARYOPHYLLATA, PLANTAGO MAJOR, PHYTOLACCA DECANDRA, ARNICA MONTANA, PHOSPHORUS, PEPTOSTREPTOCOCCUS, CARBO VEGETABILIS, HEPAR SULPHURIS CALCAREUM, L
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NDC	43742-0860-1
Set ID	c2e28444-f9a1-4009-96a6-700eda132e36
Category	HUMAN OTC DRUG LABEL
Packager	Deseret Biologicals
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Calendula Officinalis 1X, Eugenia Caryophyllata 1X, Plantago Major 1X, Phytolacca Decandra 2X, Arnica Montana 3X, Phosphorus 12X, Peptostreptococcus 15X, 30X, Carbo Vegetabilis 30C, Hepar Sulphuris Calcareum 30C, Lachesis Mutus 30C, Mercurius Solubilis 30C.
HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
WARNINGS:

Keep out of reach of children. In case of overdose, Contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.
KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.
DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.
QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com
PACKAGE LABEL DISPLAY:

DESBIO
NDC 43742-0860-1
HOMEOPATHIC
GUM
THERAPY
1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

GUM THERAPY
calendula officinalis, eugenia caryophyllata, plantago major, phytolacca decandra, arnica montana, phosphorus, peptostreptococcus, carbo vegetabilis, hepar sulphuris calcareum, lachesis mutus, mercurius solubilis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43742-0860
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_C] in 1 mL
CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321)	CLOVE	1 [hp_C] in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_C] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	2 [hp_C] in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_C] in 1 mL
PEPTOSTREPTOCOCCUS ANAEROBIUS (UNII: YQI5QWB9DU) (PEPTOSTREPTOCOCCUS ANAEROBIUS - UNII:YQI5QWB9DU)	PEPTOSTREPTOCOCCUS ANAEROBIUS	15 [hp_C] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	30 [hp_C] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	30 [hp_C] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_C] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43742-0860-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/03/2016	03/07/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/03/2016	03/07/2023

Labeler - Deseret Biologicals (940741853)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43742-0860) , api manufacture(43742-0860) , label(43742-0860) , pack(43742-0860)

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Medic

GUM THERAPY (CALENDULA OFFICINALIS, EUGENIA CARYOPHYLLATA, PLANTAGO MAJOR, PHYTOLACCA DECANDRA, ARNICA MONTANA, PHOSPHORUS, PEPTOSTREPTOCOCCUS, CARBO VEGETABILIS, HEPAR SULPHURIS CALCAREUM, L

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